Maryland has received its first shipment of two new antiviral medicines that may protect people infected with Covid-19 from becoming seriously ill or dying, state health officials announced Friday.
The drugs, Paxlovid and Molnupiravir, are given to already infected patients in the form of pills that are taken over a five day period, according to a news release from the Maryland Department of Health. Treatment must start as soon as symptoms appear.
Paxlovid, which a medical trial has estimated is 88% effective at warding off hospitalization or death from the virus, was authorized for emergency use in adults with mild to moderate Covid-19 infections by the U.S. Food and Drug Administration on Dec. 22.
Molnupiravir was given the go-ahead by the FDA the following day. A medical trial of approximately 1,400 people found that this drug reduced the likelihood of hospitalization or death from Covid-19 by about 30%, according to the FDA release.
Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, described the authorizations as “a major step forward.”
She said the drugs provide “a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge, and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”
A doctor’s prescription is needed for both medications. They are intended to treat people who have been diagnosed with Covid-19 and are at risk of becoming seriously ill.
“These two oral COVID-19 treatments are new tools to help us fight this disease and potentially save lives,” state Health Secretary Dennis R. Schrader said. “If any Marylanders test positive for COVID-19, they should speak right away with their health care provider to see if Paxlovid or Molnupiravir are right for them.”
The initial allocation of almost 5,000 doses is a fraction of the amount that will be needed to impede the progress of the pandemic, as it rampages through Maryland. More than 700,000 state residents have tested positive for Covid-19 to date; on Thursday, the state reported 14,316 new cases, a daily record. But, additional supplies of both drugs are expected to become available starting in January, the release said.
The drugs began arriving Thursday at pharmacies statewide that were “chosen to ensure equitable access of the limited supplies” the release said. A health department spokesman said in an email that Maryland has obtained about 950 doses of Paxlovid, which was developed by the Pfizer pharmaceutical company and about 4,000 doses of Molnupiravir, created by the Merck biotechnology firm.
It was not immediately known what side effects, if any, the medications may have.
Schrader emphasized that the two new drugs are used to treat Covid-19, not prevent it. Vaccinations remain the most likely method of avoiding infection.
“Getting vaccinated, getting a booster shot, and getting tested remain our best defense against COVID-19,” he said in the release.
According to the FDA, both of the new medications defeat the virus by interfering with its ability to replicate.
According to a study published on the website clinicaltrials.gov, Paxlovid was given to 1,039 patients at high risk of becoming seriously ill if they were infected with Covid-19. An additional 1,046 patients who were similarly vulnerable received a placebo. During a 28-day follow-up period, fewer than 0.8% of patients who had received Paxlovid were hospitalized or died, as compared to 6% of patients receiving the placebo.
In another study, Molnupiravir was given to 709 patients who also were at a heightened danger if exposed to Covid-19, while 699 patients swallowed a placebo. During the 29-day follow-up period, 6.8% of those who had received the drug were hospitalized or died, as compared to 9.7% of the study subjects given the placebo.
Paxlovid has been authorized for emergency use in adults and children aged 12 and older; Molnupiravir, which can inhibit bone growth, is approved on an emergency basis only those over 18. Tests are continuing into the effectiveness of both drugs, the FDA release said.
“It is important that people at risk of serious illness get tested or do an at-home test at the first sign of symptoms whether they are vaccinated or not,” Dr. Jinlene Chan, the state’s Deputy Secretary for Public Health Services, said in the news release. “These treatments need to be started within days of the onset of symptoms to be effective.”
In a related development, health officials Friday urged residents seeking COVID-19 tests to stay away from hospital emergency rooms, which are severely overtaxed by the pandemic. Instead, people who suspect they may be infected were advised to use the state’s online website for locating testing sites at https://coronavirus.maryland.gov/pages/symptoms-testing#locator.
Two new Covid-19 testing sites opened in Maryland on Friday: at the UM Upper Chesapeake Health, 500 Upper Chesapeake Dr. Bel Air and at Anne Arundel Medical Center’s South Pavilion, 2001 Medical Pkwy, Annapolis.
Neither center accepts appointments; both exclusively serve walk-in patients. They are open 9 a.m. to 3 p.m. daily, including New Year’s Day.